ClinicalTrials.gg
Active, not recruitingNCT03465254Updated May 17, 2023

Dengue Serostatus Study in the Philippines

An observational study in Dengue, Severe Dengue and Dengue Fever, sponsored by University of the Philippines. Active, not recruiting. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.

Primary conditionSevere DengueRegistry: DengueReclassifiedWhy we changed it
Registry
Dengue — the first condition term the registry derived for this study.
ClinicalTrials.gg
Severe Dengue
Why
  1. The study's listed conditions name Severe Dengue, a narrower term within Dengue.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of the Philippines · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,996
Ages
9 Years to 14 Years
Sex
All
01

Study summary

This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.

Read the detailed description

This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with \<5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.

02

Conditions studied

  • Dengue
  • Severe Dengue
  • Dengue Fever
  • Virologically-confirmed Dengue

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03

In context

Severe Dengue Reclassified

65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.

This study's enrollment of 2,996 is above the median of 667 across 13 observational studies indexed under Severe Dengue.

Browse Severe Dengue studies →

Lead sponsor

University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.

Compared within Severe Dengue, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dengue. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide signed and assent (as applicable)
  • Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization
  • Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017

Exclusion criteria

Exclusion criteria:

  • Any subject whose parent/guardian refuse to provide and/or assent
  • Children who do not belong to the specified age groups and not residents of the targeted communities
  • Children \<9 years old
  • Children with history of bleeding disorder
  • Any subject previously enrolled in a dengue vaccine clinical trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,996 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort

    Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health.

06

What researchers measure

Primary outcomes

  1. virologically-confirmed dengue (VCD)

    The primary outcome measure is virologically confirmed dengue by RT-PCR

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Lopez AL, Adams C, Ylade M, Jadi R, Daag JV, Molloy CT, Agrupis KA, Kim DR, Silva MW, Yoon IK, White L, Deen J, de Silva AM. Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study. Lancet Glob Health. 2021 Jan;9(1):e44-e51. doi: 10.1016/S2214-109X(20)30392-2. Epub 2020 Nov 16. PubMed 33212030 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03465254
Lead sponsor
University of the Philippines
Collaborators
Department of Health, Philippines, World Health Organization, Research Institute for Tropical Medicine, Philippines, University of North Carolina, La Jolla Institute for Allergy & Immunology, International Vaccine Institute
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Nov 2016
Primary completion
Oct 31, 2022
Completion
Jun 2023 (estimated)
Last update
May 17, 2023

Study contacts

Jacqueline L. Deen, MD
principal investigator · UPM-NIH, Institute of Child Health and Human Development

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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